A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Conditions

• HER2 Positive Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tucatinib — DRUG
  300 mg orally twice daily
• trastuzumab deruxtecan — DRUG
  5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle

Study Details

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.

Key Dates

Start date

Dec 1, 2020

Status verified

Mar 2026

Primary completion

Jul 15, 2024

Completion

Mar 7, 2025

Study Design

Enrollment

70 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single Arm
  Tucatinib + trastuzumab deruxtecan

Primary Outcome Measure

Confirmed Objective Response Rate (cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 According to Investigator (INV) Assessment [ Time Frame: From the first dose of study treatment until the first documented PD or before start of any new anti-cancer therapy (up to 43 months) ]

Locations (140)

Related coverage on Hipa.ai

• Trastuzumab Deruxtecan + Tucatinib Combo Shows 51.4% cORR in HER2+ Breast Cancer
  Trastuzumab Deruxtecan · Jul 31, 2025 · ClinicalTrials.gov

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